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FAQ


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  • Common FAQ
  • If The Data Statistics Company Needs To Receive The Information Of Human Genetic Resources, Does It Need To Do Information Back Up And Filing?

    If the entities other than the cooperative parties need to receive the information of human genetic resources, they need to do information back up and filing.

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  • How To Do Information Back Up And Filing When Overseas Publishing Or Participating In International Conferences Involving The Open Use Of Human Genetic Resources Information?

    The applicant should log in to the online backup platform first (https://202.108.211.75). For the first login, you need to register, submit the information backup and confirm that the backup is successful. After obtaining the information backup number, you can log in to the online filing platform (https://grants.most.gov.cn), fill in the filing application through the account of legal person or the natural person authorized by the legal person, and then submit to the Ministry of Science and Technology through the legal person account. After obtaining the filing number, the human genetic resources information can be opened for use.

    READ MORE >

  • If The Project Has Been Filed For International Cooperation, But It Needs To Be Changed To International Cooperative Scientific Research For Approval Due To Some Reason, How Should It Be Handled?

    The international cooperative research filing shall be terminated in time, the summary report shall be uploaded, and then the corresponding research can be carried out after obtaining the approval of international cooperative scientific research.

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  • When The System Displays The Filing Number Of International Cooperative Clinical Trial, Then The Clinical Trial Can Be Carried Out Without Waiting For Public Release?

    After submitting the application of international cooperative clinical trial filing, the e-system will automatically generate the filing number after formal review, then the international cooperative clinical trial can be carried out.

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  • How To Apply For Projects Beyond The Implementation Period Of The Approval For International Cooperative Scientific Research, If They Have Not Been Completed?

    A summary report on international cooperation shall be submitted in accordance with Article 26 of The Regulations on the Administration of Human Genetic Resources. If collection activities are still required, applications shall be made as new projects.

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  • Is It Necessary To Apply For Approval Of International Cooperative Scientific Research If The Involving Parties Of Ongoing Clinical Trial Project Change To Foreign Entities?

    If it is necessary to apply for the approval of international cooperative scientific research, the project shall be suspended first, and can be continued only after the approval of international cooperative scientific research.

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  • For The Approved International Cooperation Projects, During The Application For Change, Can The Clinical Trial Be Continued With Subject Screening And Recruitment?

    For the international cooperation projects which have obtained permission to use China's human genetic resources involving changes, the research can be carried out according to the original approved items before obtaining the change approval, and the changed items can only be carried out after obtaining the change approval.

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  • Is It Necessary To Apply For Changes In International Cooperative Scientific Research Activities That Do Not Involve Changes In The Types, Quantities And Uses Of Human Genetic Resources?

    If the change does not involve the change of the type, quantity and use of human genetic resources, it can be handled according to the simplified process.

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  • How To Change The Leading Site?

    The change of leading site is a major amendment, and the change application should be conducted.

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  • Does The Sponsor Of The Clinical Trial For The Purpose Of Regulatory Approval Need To Be Consistent With The Clinical Trial Approval, Notice Or Filing And Publication Materials?

    Yes; If the clinical trial sponsor is inconsistent with the clinical trial approval, notice or filing and publication materials, when filling in the application for international cooperative scientific research, it is necessary to submit relevant agreements and other supporting materials as attachments to clarify their respective rights and responsibilities.

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  • In The Clinical Trial, The Sponsor, Contract Research Organization And Other Cooperative Parties Are All Chinese Entities, And Only EDC Suppliers Are Foreign Entity. Is It Necessary To Apply For Approval Of International Cooperative Scientific Research?

    Ans: There is no need to apply for approval of international cooperative scientific research.

    READ MORE >

  • Which Units Belong To “other Units” For International Cooperative Scientific Research Project?

    All units except the clinical trial sponsor, medical institution (leading site), contract research organization and third-party laboratory are "other units".

    READ MORE >

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